PARACETAMOL CINFA 650 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Cinfa 650 mg Film-Coated Tablets EFG

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Paracetamol Cinfa is and what it is used for
2. What you need to know before taking Paracetamol Cinfa
3. How to take Paracetamol Cinfa
4. Possible side effects

1. Storage of Paracetamol Cinfa
2. Contents of the pack and further information

1. What Paracetamol Cinfa is and what it is used for

Paracetamol Cinfa belongs to a group of medicines called analgesics and antipyretics.

This medicine is used for the occasional treatment of mild to moderate pain and fever.

2. What you need to know before taking Paracetamol Cinfa

Do not take Paracetamol Cinfa

• If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paracetamol Cinfa.

• Do not take more than the recommended dose of this medicine (see section 3, How to take Paracetamol Cinfa).
• Avoid taking this medicine at the same time as other medicines that contain paracetamol, such as medicines for colds and flu, as high doses can lead to liver damage. Do not take more than one medicine that contains paracetamol without consulting your doctor.
• In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have any liver, kidney, heart, or lung disease, anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells), or suffer from chronic malnutrition or dehydration, consult your doctor before taking this medicine.
• When being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as the effectiveness of paracetamol may be reduced and the risk of liver toxicity increased, especially with high doses of paracetamol.
• In chronic alcoholics, do not take more than 3 tablets of 650 mg of paracetamol in 24 hours.
• If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic), a serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

This medicine should not be used in children under 6 years of age (weight less than 22 kg), as it does not allow for the administration of doses lower than 325 mg of paracetamol.

In children and adolescents under 15 years of age, consult your doctor or pharmacist, as other presentations with adapted paracetamol doses for these patients may be available.

Interference with laboratory tests

If you are going to have any laboratory tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Paracetamol may alter the values of uric acid and glucose determinations.

Other medicines and Paracetamol Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medicines to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines to treat tuberculosis: isoniazid, rifampicin.
• Medicines to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower cholesterol levels in the blood: colestyramine.
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.

Also inform your doctor or pharmacist if you are taking:

- flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that should be treated urgently (see section 2).

Do not use with other pain relievers (medicines that reduce pain) without consulting your doctor.

In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Taking Paracetamol Cinfa with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic beverages per day: beer, wine, liquor) may cause liver damage.

Taking this medicine with food does not affect its effectiveness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

In case of need, paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor before using this medicine.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is negligible or non-existent.

Paracetamol Cinfa contains hydrogenated castor oil

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

Paracetamol Cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Paracetamol Cinfa

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents over 15 years (and weight over 50 kg)

The recommended dose for adults is half to 1 tablet (325 mg to 650 mg of paracetamol) every 4-6 hours. Do not take more than 4 and a half tablets (approximately 3 g) every 24 hours.

The minimum interval between doses will not be less than 4 hours.

In the case of adults with low weight (40 kg or less), they may follow the dosage recommendations for children, although there are other presentations with adapted paracetamol doses for these patients; ask your doctor or pharmacist.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of adverse effects such as liver damage increases.

Patients with kidney or liver disease

They should consult their doctor.

Elderly patients

They should consult their doctor.

Use in children and adolescents

The defined doses based on weight must be respected. The child's age based on weight is provided for informational purposes.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

Children under 6 years

They should consult their doctor, as other presentations with adapted doses for these patients are available.

Children with weight over 22 kg, up to 33 kg (approximately 6 to 9 years)

Half a tablet (325 mg of paracetamol) every 4-6 hours, depending on the child's weight, up to a maximum of 2-3 tablets (1,300 mg-1,950 mg of paracetamol) every 24 hours, depending on the patient's weight. The time interval between each administration and the maximum daily dose will depend on the patient's weight.

Children with weight over 33 kg, up to 43 kg (approximately 10-12 years)

Half a tablet (325 mg of paracetamol) every 4 hours, up to 1 tablet every 6 hours, depending on the patient's weight. The maximum dose will be 3-4 tablets of paracetamol (1,950 mg-2,600 mg of paracetamol) every 24 hours, depending on the patient's weight.

Adolescents with weight over 43 kg (from 13 years of age)

1 tablet (650 mg of paracetamol) every 4-6 hours, not exceeding 4 tablets every 24 hours (2,600 mg of paracetamol).

If the pain persists for more than 5 days (more than 3 days in children) or 2 days for throat pain, the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, stop treatment and consult your doctor.

Method of administration

The tablets should be taken orally with a glass of water.

The tablet can be divided into equal doses.

For quick relief of pain, take the medicine without food.

If you think the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist.

If you take more Paracetamol Cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

If you have ingested an overdose, go quickly to a medical center, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of the overdose is more effective if started within 4 hours after ingestion of the medicine.

Treatment includes:

• Stomach lavage.
• Oral administration of activated charcoal.
• Hemodialysis.
• Administration of acetylcysteine at adequate doses.

Patients being treated with barbiturates (a type of sedative medicine) or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamol Cinfa

Do not take a double dose to make up for forgotten doses.

Take the forgotten dose when you remember and take the next doses with the indicated interval between doses (4-6 hours).

If you stop taking Paracetamol Cinfa

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects(may affect up to 1 in 1,000 patients) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects(may affect up to 1 in 10,000 patients) are: kidney disease, cloudy urine, severe skin reactions, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Side effects with unknown frequency(cannot be estimated from available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Paracetamol can damage the liver when taken in high doses or for prolonged treatments.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Cinfa

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the package after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Cinfa

• The active ingredient is paracetamol. Each tablet contains 650 mg of paracetamol.
• The other ingredients are:
• • Core of the tablet: anhydrous colloidal silica, cornstarch, microcrystalline cellulose (E-460), magnesium stearate (E-470b), sodium carboxymethylcellulose (type A) (from potato), hydrogenated castor oil, povidone (E-1201).
  • Coating of the tablet: macrogol 6000, hypromellose 606, and hypromellose 615 (E-464).

Appearance of the product and contents of the pack

Paracetamol Cinfa 650 mg film-coated tablets EFG are oblong, coated, biconvex tablets, white in color, with a score line on one side and a code on the other.

They are presented in PVC-PVDC/ALU blisters. Each package contains 20, 40, or 500 (clinical package) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10 - Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

or

GALENICUM HEALTH, S.L.

Avda. de Cornella 144, 7º- 1ª Edificio LEKLA,

Esplugues de Llobregat, 08950 Barcelona

Date of the last revision of this package leaflet:February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

You can access detailed and updated information about this medicine by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/68066/P_68066.html

QR code to: https://cima.aemps.es/cima/dochtml/p/68066/P_68066.html